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临床试验/NCT03273140
NCT03273140已完成不适用

The Effectiveness of Gamification Diabetes Education Program for Poorly Controlled Type 2 Diabetic Patients: A Randomised Controlled Trial.

National Healthcare Group, Singapore1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
158
试验地点
1
主要终点
Better Sense of Coherence

研究概览

简要总结

Background: The prevalence of DM is increasing across both Asian and Western countries, in proportion to the rising aging population. Type 2 diabetic patients are the high-risk group to experience diabetes-related complications that can lead to depression, poor quality of life and even death. In the current face-to-face diabetes counseling, the patients presented with weak comprehension of diabetes knowledge. There is a gap between application of knowledge and self-efficacy behaviors. With the increased patient acuity in the recent years, it has contributed to the shortage of diabetes nurse educators to meet the demands or needs in the outpatient endocrine clinic. Often, the patients have to wait longer for their turn for diabetes education, which can result in a delay in diabetes self-management. The use of mobile health technologies had demonstrated a positive impact on diabetes-related outcomes and better self-efficacy behaviors, all of which are crucial in diabetes management.

Aims: This study is to evaluate the effectiveness of Gamification Diabetes Education Program (GDEP) on HbA1c values, self-efficacy, sense of coherence and quality of life among the poorly controlled 2 diabetic patients.

Methods: This study adopted a randomized control trial design. Based on Cohen's power analysis, one hundred and forty-eight participants will be recruited through simple random sampling. The recruitment process includes block randomization and allocation concealment. Participants will either be randomized into intervention (GDEP) group or control (current practice) group. The self-efficacy instrument, sense of coherence scale (SOC-13), world health organisation quality of life scale- brief (WHOQoL-BREF) and HbA1c values assessed the outcomes at the same time points: point of enrollment (pre) and two post-time points at 12-week and 24-week.

The significance of study: GDEP would bring about awareness on diabetes management and contribute to existing diabetes literature. It addresses the clinical significance of enhancing diabetes knowledge and motivation in self-efficacy behaviors. Hence, GDEP has the potential to close the gap between application of knowledge to self-efficacy behaviors, which in turn would result in better self-efficacy, sense of coherence and quality of life. All of these could reduce their HbA1c values and the global health care expenditure spent on managing diabetes mellitus alone. The development of GDEP is a value-added and innovative-driven packaging to close the gap and address the limitation in the current literature. It serves to transform workforce and redesign patient education process for type 2 diabetic patients.

详细描述

The prevalence of Diabetes Mellitus (DM) is increasing internationally, corresponding with the rising aging population. Nearly half of the population was unaware that they have diabetes and the number is portended to reach 439 million worldwide by the year 2030. This global phenomenon draws the attention on the enormous health care expenditure spent on managing DM alone. The financial burden of diagnosed diabetes was 2.3 times higher than the absence of it, reflecting as one of the barriers in engaging diabetes patients and promoting self-efficacy. Type 2 diabetes patients, also known as non-insulin dependent diabetes, are the high-risk population to experience a diabetes-related complication, such as, end-stage renal failure (ESRF), stroke, cardiovascular disease and amputation of the limbs, all of which can lead to poor quality of life (QoL), depression and even death.

Local statistics demonstrated an increase of 25.6% (2013 to 2015) of diabetic patients in an outpatient endocrinology clinic and ten percent hospital readmission rate of patients due to poor compliance and diabetes-related health issues. A retrospective study done locally in the primary health care polyclinics had shown an incline percentage of attendances with DM, from 8.8% to 9.8% over the past five years (2011 to 2015), reflecting an increase of 8155 diabetic patients. Their average age group is 40 years old. According to American Diabetes Association (ADA, 2014), glycosylated hemoglobin A1c (HbA1c) value has been recognized as the standard measurement in diagnosing and treating DM and, the value of ≤7% was correlated with a reduction in diabetes complications. Each 1% of the reduction in HbA1c values over ten years is equivalent to 21% of the reduced risk of diabetes-related outcomes and death, including 14% of the reduced risk for myocardial infarcts and 37% for microvascular complication (p<0.0001). Effective diabetes management or self-efficacy appears strongly related to healthy lifestyle modification and behavioral change, such as medication adherence, compliance to treatment-regime and exercising.

In comparison, poor access to quality care, stress, and obesity has a detrimental effect on HbA1c values and increased the risk for diabetes-related complication as mentioned. Poor clinical outcomes consists of HbA1c >7.0%, systolic blood pressure > 130mmHg, body mass index (BMI) of ≥ 25, abnormal low-density lipoprotein (LDL) and high-density lipoprotein (HDL) measurement. Poor diabetes outcomes are related to depressive symptoms, anxiety, low self-efficacy, poor self-esteem, eating disorders and diabetes-related stress, including osteoporosis among the Chinese diabetes patients. Hence, diabetes patient education is an important cornerstone in self-management, self-efficacy, and long-term behavior change.

Patient education is defined as a process of providing skills and knowledge, including giving advice and alternatives for lifestyle modification in diabetes management and glycemic control. Health education aimed at preventing diabetes-related complications and can lead to improved health literacy that supports greater empowerment in health decision-making and outcomes. There is no consistency of teaching contents in diabetes educational program. It could be due to that the program was led by a different healthcare professional, such as pharmacist, dietician or nutritionist, diabetes nurse educator and or psychologist.

To some extent, the benefits of these diabetes education programs had shown improvement in self-management and glycemic control, including a reduction in depression, and enhancing self-efficacy behaviors and better quality of life. However, all these require an ongoing positive reinforcement in order to achieve a successful long-term intervention and good glycemic control. An effective diabetic patient education would mean success in diabetic self-management, which is associated with better metabolic control, lower costs of therapy through complication prevention, lower mortality rate, reduced readmission rates, improve QoL and, better self-efficacy and health behaviors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

Assessor blinding is not possible as the researcher is involved in the whole process from recruitment to data analysis as part of her doctorate study. However, a research assistant (RA) will assist in arranging the sequence of the envelopes as part of allocation concealment, double-checking of the data entry and analysis of the report. To highlight, the RA will also not know which is the 'control' and 'intervention' group, as both groups will be de-identified as group A and B during the process of data entry and analysis.

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patient who is clinically diagnosed with type 2 diabetes mellitus.
  • •Patient with HbA1C value > 7% at least within the past two months.
  • •Patient who can speak and understand English.
  • •Patient of age 21 to 75 years old.
  • •Patient with either a smartphone or i-pad/ tablet.

排除标准

  • •Pregnant patient.
  • •Patient diagnosed to have a terminal illness.
  • •Patient with cognitive impairment.
  • •Patient with end-stage renal failure (ESRF).

研究组 & 干预措施

Gamification Diabetes Education Program (GDEP)

Experimental

The GDEP consists of two components, which are 1) gamification app on diabetes education, and 2) usual care group (face-to-face discussion with a DNE).

  1. Gamification: The development of this gamification app, a mobile-based app of serious gaming, addresses the limitation and few recommendations from the current literature review. It aimed to enhance the user experience, and to facilitate diabetes education in an effective and efficient way, aligning with ADA (2014) guidelines, work instructions, and protocols in one tertiary organization. The learning modules are framed by socio-cognitive framework and self-efficacy. The gaming concept has been implemented into a mobile app, which can be accessed via iOS and Android platforms. It takes an average of 15 minutes to complete per stage. Hence, allowing flexibility for participants to access the games anywhere and anytime using i-pad or mobile devices.

干预措施: Gamification Diabetes Education Program (GDEP) (Device)

Standard group

No Intervention

The control group comprises of the standard care or usual care group, which is the face-to-face session with the DNE. The content during each session is dependent upon the individual's needs and concerns, including the reason for referral to DNE by the endocrinologist. For example, teaching the individual patient on self-management of blood glucose (SMBG) and emphasizing on diet modification and exercise if necessary. Educational pamphlets on diabetes management will be given to him/her if deemed necessary. Each session will usually requires an average of 45 minutes, which is considered as long consultation that costs 16 dollars. On the other hand, short consultation is categorised as less than 30 minutes that costs around eight dollars. The difference is that there is no GDEP in the control group. However, after the completion of data collection at six months time, the control group will also receive the intervention (GDEP). This is in order to give them equal opportunity.

结局指标

主要结局

Better Sense of Coherence

时间窗: Every three months up to 24th week (0 week as baseline, 12th week and 24th week)

Using SOC-13

Better HbA1c values

时间窗: Every three months up to 24th week (0 week as baseline, 12th week and 24th week)

Clinical indicator to monitor glycemic control for the past three months

Better Self-efficacy

时间窗: Every three months up to 24th week (0 week as baseline, 12th week and 24th week)

Using Self-efficacy tool (Duprez et al., 2013)

次要结局

  • Better Quality of life(Every three months up to 24th week (0 week as baseline, 12th week and 24th week))

研究者

发起方
National Healthcare Group, Singapore
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

KHO SIOK EE SHARON

Principal Investigator, Clinical Instructor

National Healthcare Group, Singapore

研究点 (1)

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